CLASS II Drug recall · Reported 22 Aug 2018 · FDA Enforcement Report

Valsartan, 160 mg recalled by Northwind Pharmaceuticals

Northwind Pharmaceuticals is recalling Valsartan, 160 mg per, distributed in Indiana. The recall was initiated on 18 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: UT48320002, exp 07/31/2018; Lot UT48320003, exp 05/31/2019

Quantity recalled68 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1095-2018
FDA event ID: 80703
Recalling firm: Northwind Pharmaceuticals, Indianapolis, IN
Classification: Class II
Status: Terminated
Recall initiated: 18 Jul 2018
FDA classified: 15 Aug 2018
Reported: 22 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Blood Pressure Medication

Timeline

18 Jul 2018	Recall initiated by company
15 Aug 2018	Classified by FDA	+28 days
22 Aug 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52

Where it was distributed

Indiana

Questions about this recall

Why was it recalled?

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Which lots are affected?

Lot: UT48320002, exp 07/31/2018; Lot UT48320003, exp 05/31/2019

Where was it sold?

Indiana

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 80703

This product is part of a recall event; the main page for the event is Valsartan HCTZ, 160/12.5mg recalled by Northwind Pharmaceuticals.

Reported	Class	Recall	Company	Reason	Where
22 Aug 2018	CLASS II	Valsartan HCTZ, 160/12.5mg recalled by Northwind Pharmaceuticals	Northwind Pharmaceuticals	Potency & Assay	IN
22 Aug 2018	CLASS II	Valsartan, 320mg recalled by Northwind Pharmaceuticals	Northwind Pharmaceuticals	Potency & Assay	IN
22 Aug 2018	CLASS II	Valsartan, 80mg recalled by Northwind Pharmaceuticals	Northwind Pharmaceuticals	Potency & Assay	IN

More recalls from Northwind Pharmaceuticals

All 13

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets recalledSulfamethoxazole And Trimethoprim	Northwind Pharmaceuticals	Packaging Defects	Nationwide
3 May 2023Drug	CLASS II	Glimepiride Tablets, USP 4mg recalled by Northwind PharmaceuticalsGlimepiride	Northwind Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
3 May 2023Drug	CLASS II	Tadalafil Tablets, USP 5 mg recalled by Northwind PharmaceuticalsTadalafil	Northwind Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
3 May 2023Drug	CLASS II	Doxazosin Tablets, USP, 4mg recalled by Northwind PharmaceuticalsDoxazosin	Northwind Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
3 May 2023Drug	CLASS II	Atorvastatin Calcium Tablets, USP, 10 mg recalledAtorvastatin Calcium	Northwind Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

Other Valsartan recalls

All 88

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Drug	CLASS II	Diovan (valsartan) 160 mg recalled by Novartis PharmaceuticalsDiovan	Novartis Pharmaceuticals	Potency & Assay	Nationwide
2 Jun 2021Drug	CLASS II	Valsartan Tablets recalled by Cardinal HealthValsartan	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
27 Mar 2019Drug	CLASS II	Valsartan Tablets 160 mg recalled by Rising Pharmaceuticals	Rising Pharmaceuticals	Nitrosamine Impurity	Nationwide
27 Mar 2019Drug	CLASS II	Valsartan Tablets USP 80 mg recalled by Aurobindo Pharma USAValsartan	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
27 Mar 2019Drug	CLASS II	Valsartan Tablets USP 320 mg recalled by Aurobindo Pharma USAValsartan	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide